Congress Adds Some Teeth To FDA’s Authority To Regulate Cosmetics – Food and Drugs Law
Key Takeaways:
- For decades, cosmetics have largely been subject to fewer
regulations and less stringent oversight than other products
regulated by FDA. At the end of last year, Congress provided FDA
with stronger tools to regulate, monitor, and enforce against
unsafe or otherwise non-compliant cosmetic products. - As a result of these amendments, cosmetic companies will soon
be subject to new requirements for registration, product listing,
disclosure of ingredients, adverse event reporting, safety
substantiation, and compliance with good manufacturing
practice. - Transitioning from a regime that depended by and large on
voluntary compliance to more active regulation and oversight will
require FDA to promulgate new regulations and issue additional
guidance for industry.
Introduction
The Food and Drug Administration (FDA) now has additional
regulatory authorities over cosmetics, thanks to the Food and Drug
Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated
Appropriations Act, 2023 (the omnibus spending package that
Congress passed late last year) and it amended the Federal Food,
Drug, and Cosmetics Act (FDCA) to, among other things, provide FDA
with additional oversight tools over cosmetics. The FDORA subtitle
amending the FDCA cosmetics requirements is entitled
“Modernization of Cosmetics Regulation Act of
2022″(MCRA).1
Background on Cosmetic Regulation Prior to MCRA
The FDCA defines cosmetics as “articles intended to be
rubbed, poured, sprinkled, or sprayed on, introduced into, or
otherwise applied to the human body or any part thereof for
cleansing, beautifying, promoting attractiveness, or altering the
appearance.” The definition excludes “soap” but
encompasses a variety of personal care products, including skin
moisturizers and lotions, perfumes, hair care products and color,
deodorant, makeup, and components of such products.
Some personal care products, i.e. those with therapeutic
intended uses, are also regulated as drugs or medical devices and
are therefore subject to additional requirements such as premarket
review or conformance with an over-the-counter (OTC) monograph,
which specifies conditions to ensure the covered products are
generally recognized as safe and effective and not misbranded. For
example, a toothpaste is a paste, gel, liquid, or other preparation
that is intended for cleaning teeth and is regulated as a
“cosmetic.” If a toothpaste also is intended to prevent
the formation of dental caries, it also is subject to the monograph
for OTC anticaries drug products.2 The monograph
specifies the permissible active ingredients, including the
concentration and dosage form for each ingredient, packaging
conditions, labeling conditions, and procedures to test for caries
reduction.
Personal care products that are regulated solely as cosmetics
have not been subject to such requirements, because FDA’s
statutory authority over cosmetics has been far less comprehensive
than the agency’s authority over other products it regulates.
FDA can conduct inspections of cosmetic manufacturers and take
certain actions against adulterated or misbranded cosmetics under
the FDCA, such as issuing import alerts and/or warning letters to
responsible entities, and it can enlist the Department of Justice
to initiate legal action seeking an injunction, seizure, or even
criminal penalties for egregious violations. A cosmetic is
adulterated, for example, if it has been produced in an unsanitary
manner or if it contains an injurious or unsanitary substance or an
unsafe color additive (other than certain coal-tar hair dyes with
requisite disclaimers).3 A cosmetic can be deemed
misbranded, for example, if its labeling is false or misleading or
if its packaging or labeling fails to contain requisite information
or conform to certain requirements.4
But FDA has had little authority to regulate these products
before they are introduced into commerce or effectively monitor the
products once they have reached the market. First, cosmetic
formulations are not reviewed by FDA prior to being sold to
consumers, and although cosmetic firms are responsible for
substantiating the safety of their products and ingredients prior
to marketing them in the U.S., many of FDA’s cosmetics
guidelines provide the industry with “considerable flexibility
regarding product development and claims.”5 With
respect to cosmetic ingredients, only color additives must be
approved by FDA for their intended use. In addition, FDA has had
limited authority to require companies to perform safety testing,
follow good manufacturing practices, submit adverse event reports,
recall their products, or even register their facilities with FDA
and has instead depended upon voluntary compliance with recommended
guidelines and procedures.
New Requirements Added by MCRA
Even under the new law, cosmetic products and ingredients (other
than color additives) will not require premarket
notification or FDA review or approval before they are
commercially marketed. The amendment, however, will require
companies to register their cosmetic manufacturing
or processing facilities with FDA and list the cosmetic
products associated with these facilities.6
This would include any facility that makes any cosmetic product
“by chemical, physical, biological, or other procedures,
including manipulation, sampling, testing, or control procedures
applied to the product” but would exclude establishments such
as beauty shops and salons (that do not make cosmetics), retailers,
distributors, and establishments that only perform certain
manufacturing functions, such as labeling and
packaging.7
FDA’s regulations currently request that cosmetic companies
disclose a list of ingredients to FDA within 60 days after the
beginning of commercial distribution of the product and identify
the product’s intended use category. Not only has this
procedure been voluntary, manufacturers who chose to submit a
statement were permitted to list certain ingredients as
“fragrances” or “flavors” without disclosing
the product name or trade name of the ingredient or
supplier.8 Under the new law, a manufacturer will be
required to provide a list of ingredients when it
registers its facility and lists its products with FDA. The label
of each cosmetic product will also be required to identify each
“fragrance allergen” included in the product, once FDA
promulgates regulations determining which substances are fragrance
allergens.9 Moreover, if FDA has “reasonable
grounds to believe” that a fragrance or flavor ingredient may
have contributed to a serious adverse event (explained below), it
now has the authority to obtain a list of the ingredients in the
specific fragrances or flavors in the cosmetic product from the
manufacturer.10
Cosmetic product manufacturers will also now be required to
comply with adverse event reporting and record
retention requirements.11 More specifically,
cosmetic companies will only be required to report serious adverse
events to FDA, but they will need to maintain records of all
reports of adverse health-related events associated with the use of
their products that they receive. For an adverse event to be
considered serious, and thus reportable, it must have resulted
in—or required a medical or surgical intervention to
prevent—death, a life-threatening experience, inpatient
hospitalization, a persistent or significant disability or
incapacity, a congenital anomaly or birth defect, an infection, or
significant disfigurement. The new law will require all adverse
event records to be maintained for 6 years and be subject to
inspection by FDA.
The new law also explicitly requires a cosmetic product
manufacturer to ensure and maintain records supporting that there
is “adequate substantiation of safety“
of the product, which is defined as “tests or studies,
research, analyses, or other evidence or information that is
considered, among experts qualified by scientific training and
experience to evaluate the safety of cosmetic products and their
ingredients, sufficient to support a reasonable certainty that a
cosmetic product is safe.”12 A cosmetic product is
“safe” under the new law if the formulated product or
none of the ingredients are injurious to users if the product is
used as directed by the label or in a manner that is customary or
usual for such a product.
The statute explains that a cosmetic product or ingredient would
not be considered injurious to users solely on the basis of the
potential to “cause minor and transient” reactions or
skin irritations in some users. However, the statute also clarifies
that FDA may consider “the cumulative or other
relevant exposure to the cosmetic product, including any
ingredient thereof” when determining whether a product is
injurious. This is a critical win for consumer advocates, who have
long been calling for FDA to consider the effect of cumulative
exposure to cosmetic ingredients and take appropriate
action.13 Similarly, the new law requires FDA to
promulgate regulations establishing testing methods for detecting
and identifying talc-containing cosmetic products14 and
to assess the use and safety of perfluroroalkyl and perfluroroalkyl
substances (PFAS) in cosmetic products.15
Another important measure in MCRA is a requirement that FDA
issue regulations to outline good manufacturing practices
(GMPs) for cosmetic products. Although FDA has previously
released GMP guidelines for cosmetics, manufacturers were not
required to follow them. MCRA tasks FDA with establishing GMP
guidelines by regulation that are consistent with national and
international standards but also “take into account the size
and scope of the businesses engaged in the manufacture of
cosmetics, and the risks to public health posed by such cosmetics,
and provide sufficient flexibility to be practicable for all sizes
and types of facilities to which such regulations will
apply.”16 MCRA gives FDA express authority to
inspect records necessary to demonstrate compliance with the GMPs.
Before issuing the GMP regulations, FDA is required to consult with
cosmetics manufacturers, publish a notice of proposed rulemaking,
and publish a final rule within three years of the statute’s
enactment. Manufacturing a cosmetic product that fails to meet
these GMPs would render the product adulterated under MCRA.
MCRA authorizes FDA to enforce these new provisions by expressly
making failure to comply with these requirements prohibited
acts under the FDCA.17 Moreover, MCRA provides
FDA with mandatory recall authority over a
cosmetic product if it determines that a reasonable probability
exists that the product is adulterated or misbranded and “the
use of or exposure to the product will cause serious adverse health
consequences or death.”18 FDA can also suspend the
registration of a cosmetic facility if it determines that a
cosmetic product manufactured or processed by that facility has a
reasonable probability of causing serious adverse health
consequences or death to humans and that other products
manufactured or processed by the facility may be similarly
affected.19
A few additional provisions are worth mentioning. First, MCRA
includes an express preemption clause, which
precludes a state from establishing or continuing in effect any
different requirements for cosmetics related to registration and
listing, GMP, records, recalls, adverse event reporting, or safety
substantiation, however, the provision allows states to
prohibit the use or limit the amount of an ingredient in a
cosmetic product and to continue any requirements for reporting
cosmetic ingredients that existed prior to the enactment of
MCRA.20 Secondly, MCRA exempts small
businesses from the GMP, registration, and product listing
requirements, provided that the companies do not manufacture
certain products, such as those that are injected or intended for
internal use.21 Products and facilities that are also
subject to drug or device GMP regulations are also exempt from
these requirements as well as MCRA’s adverse event reporting,
safety substantiation, recordkeeping, and labeling
provisions.22
Conclusion
Now that Congress has changed the law to give FDA more teeth,
the public will have to wait and see how hard the agency will bite.
How FDA implements and uses its new authorities under MCRA will be
a matter of great interest to cosmetic manufacturers and consumers
alike. These new requirements will be introduced on a rolling
basis. For example, the registration and listing requirements will
be effective as of the end of this year and the statute requires
FDA to promulgate labeling and CGMP regulations within the next two
to three years. In any case, before the start of any FDA regulatory
activity, it will be incumbent on companies in the cosmetics
industry (new and established alike) to gain an understanding of
what these new requirements mean for their businesses. If you would
like to discuss these implications, please feel free to reach out
to Foley Hoag attorneys Bryant Godfrey and Tina
Papagiannopoulos.
Footnotes
1. Consol. Approps. Act, 2023, Pub. L. 117-328, Division
FF, Title III, Subtitle E – Cosmetics, sec. 3501-3508, 136
Stat. 4459 (2022) [hereinafter, “Modernization of Cosmetics
Regulation Act of 2022” or “MCRA”].
2. Final Rule, Final Monograph, Anticaries Drug Products
for Over-the-Counter Human Use, 60 Fed. Reg. 52474 (Oct. 6,
1995).
3. 21 U.S.C. § 361.
4. 21 U.S.C. § 362.
5. Cong. Research Serv., FDA Regulation of Cosmetics and
Personal Care Products (Mar. 9, 2022) at 2, https://crsreports.congress.gov/product/pdf/R/R42594/4.
6. MCRA, supra note 1, sec. 3502, § 607.
7. 21 C.F.R. 700.3(k).
8. 21 C.F.R. Part 720; MCRA, supra note 1, sec. 3502,
§ 604.
9. MCRA, supra note 1, sec. 3502, § 609.
10. Id. at 3502, § 605(f).
11. Id. at 3502, § 605.
12. Id. at 3502, § 608.
13. See, e.g., Environmental Working Group, “Lose
the Lilial: European Union Ban Shows Risks of Chemical in
Cosmetics,” https://www.ewg.org/news-insights/news/2022/03/lose-lilial-european-union-ban-shows-risks-chemical-cosmetics.
14. MCRA, supra note 1, sec. 3505.
15. Id. at sec. 3506.
16. Id. at sec. 3502, §. 606
17. Id. at sec. 3503.
18. Id. at sec. 3502, § 611.
19. Id. at sec. 3502, § 607.
20. Id. at sec. 3502, § 614.
21. Id. at sec. 3502, § 612.
22. Id. at sec. 3502, § 613.
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